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DUOLITH SD1 »ultra« from STORZ MEDICAL approved in the USA for wound management of diabetic foot ulcers (DFU)


The DUOLITH® SD1 »ultra« with the C-ACTOR® »SEPIA« handpiece has been approved in the USA since late February 2021 as a Class II device for the treatment of chronic diabetic foot ulcers (DFU).

According to the regulatory approval by the FDA, DUOLITH® SD1 »ultra« can be used to treat wounds with an area that does not exceed 16 cm2 and which extend over epidermis and dermis to tendon or capsule (not to bone). The treatment has been approved for diabetic patients 22 years of age and older with a foot ulcer that has been present for more than 30 days.

»We are pleased that wound healing specialists in the USA can now use the DUOLITH® SD1 »ultra« as part of their multimodal therapy plans. We strongly believe that our non-invasive technology can make an important contribution to the treatment of chronic diabetic foot ulcers«, said STORZ MEDICAL's Director of Research and Development, Dr Rafael Storz.

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